Quality Assurance Specialist

hace 1 mes

Ciudad de México, Ciudad de México Marken A tiempo completo
About the Role

We are seeking a highly skilled Quality Assurance Associate to join our team at Marken. As a critical part of UPS Healthcare, we provide state-of-the-art GMP-compliant depot networks and logistic hubs for clinical drug product storage and distribution worldwide.

Job Summary

The successful candidate will be responsible for overseeing and implementing the Marken Quality Management System (QMS), ensuring compliance with applicable regional and local regulations, customer requirements, and company policies.

Main Responsibilities
  • Implement, communicate, and maintain company quality systems in compliance with global QMS requirements.
  • Interact with clients on QA/GxP-related matters under management supervision.
  • Effectively interact with Marken departments and stakeholders to support all QA tasks.
  • Support internal audits, client audits, and regulatory inspections.
  • Collate issues, CAPA, risk assessment, change control, and training metrics, identifying quality improvement initiatives.
  • Ensure accuracy and quality of records and documents.
  • Participate actively in internal quality meetings.
Requirements

To be considered for this role, you should have:

  • Minimum 1 year of experience in a Quality Assurance role within a GSP/GMP/GDP/GCP regulated position.
  • High/Secondary School diploma or equivalent with relevant job-related skills.
  • Related knowledge of Good Manufacturing Practice, Good Clinical Practice, Good Distribution Practice, and Good Storage Practice guidelines.
  • Detailed-oriented, oral and written communication skills, good interpersonal skills, organized, methodical, and efficient approach to work.
  • Proficient use of Microsoft Office and fluency in English, multilingualism in Spanish and English preferred.
  • Knowledge of cold chain supplies and logistics, storage, and distribution for pharmaceutical products preferred.
Benefits

This is an excellent opportunity to work with a leading company in the healthcare industry, offering competitive salaries and benefits packages.

The estimated salary range for this position is $60,000 - $80,000 per annum, depending on location and experience.

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